CP-675,206 With Neoadjuvant Hormone Therapy in Patients With High Risk Prostate Cancer
Completed · Phase 1/Phase 2
Conditions studied: Prostatic Neoplasms
In brief
This is a multi-center, open label, randomized study. Patients will be randomized to one of the following arms with an allocation ratio of 3:1, respectively: Arm A: CP-675,206 + neoadjuvant hormone therapy (NHT) OR Arm B: neoadjuvant hormone therapy. After randomization, patients will receive study treatment for three cycles (one cycle is defined as 28 days). After completion of three cycles, patients will undergo a prostatectomy and pathology assessments will be completed at a central laboratory, the Armed Forces Institute of Pathology (AFIP) in Washington, DC.
Key facts
- Study ID
- NCT00075192
- Run by
- AstraZeneca
- People needed
- 8
- Starts
- 2004-03-01
- Expected to finish
- 2006-03-01
- Last updated by the study team
- 2012-06-06
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed adenocarcinoma of the prostate, previously untreated
- Potential candidate for radical prostatectomy on the basis of the patient's general medical condition, performance status, and life expectancy
- Potential candidate for NHT prior to prostatectomy, including high or intermediate risk of recurrence, based on an estimated risk of biochemical recurrence: High risk category: PSA >20 or Gleason score 8 or cT2c/cT3 OR Intermediate risk category: PSA >10 and d20 or Gleason score 7 or cT2b
- No evidence of metastatic disease by physical examination, bone scan, and computed tomography, or MRI, of the abdomen and pelvis
- Age > 18 years
- ECOG performance status 0-1
- Adequate bone marrow, hepatic, and renal function determined within 2 weeks prior to starting therapy
- Availability of prostatectomy specimen for histological analysis at the Armed Forces Institute of Pathology
You may not qualify if…
- Prior hormone therapy, radiation, chemotherapy, or immunologic therapy for prostate cancer
- History of, or significant risk for, chronic inflammatory or autoimmune disease
- Potential requirement for systemic corticosteroids before surgery based on prior history
- History of autoimmune colitis or chronic GI conditions associated with diarrhea or bleeding, or current acute colitis of any origin
- Any serious uncontrolled medical disorder or active infection which would impair ability to receive study treatment and subsequent prostatectomy
- Coexisting malignancies except basal or squamous cell carcinoma of the skin
Where it is running
- Research Site — La Masa, California, United States
- Research Site — Washington D.C., District of Columbia, United States
- Research Site — Gallatin, Tennessee, United States
- Research Site — Hermitage, Tennessee, United States
- Research Site — Lebanon, Tennessee, United States
- Research Site — Murfreesboro, Tennessee, United States
- Research Site — Nashville, Tennessee, United States
- Research Site — Nashville, Tennessee, United States
- Research Site — Nashville, Tennessee, United States
- Research Site — Nashville, Tennessee, United States
- Research Site — Smyrna, Tennessee, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.